TriangleNCT04209465 · OUTCOME
Number of Dose Limiting Toxicities as a Determinant of the Recommended Phase 2 Dose (RP2D)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- After the first dose of treatment for up to 21 days.
What was measured
Certain toxicities will be considered dose-limiting unless clearly attributable to an extraneous cause, such as underlying disease.
Analysis population: DLT-Evaluable
Groups in this outcome
25 mg QD
Patients who received doses at 25 mg once daily under fasted conditions.
50 mg QD
Patients who received doses at 50 mg once daily under fasted conditions.
100 mg QD
Patients who received doses at 100 mg once daily under fasted conditions.
200 mg QD
Patients who received doses at 200 mg once daily under fasted conditions.
400 mg QD
Patients dosed at 400 mg once daily under fasted conditions
800 mg QD Fasted
Patients enrolled at 800 mg once daily under fasted conditions
800 mg QD Not Fasted
Patients enrolled at 800 mg once daily under not fasted conditions
1000 mg QD
Patients enrolled at 1000 mg once daily under not fasted conditions
1200 mg QD
Patients enrolled at 1200 mg once daily under fasted conditions
400 mg BID
Patients enrolled at 400 mg twice daily under not fasted conditions
600 mg BID
Patients enrolled at 600 mg twice daily under not fasted conditions
800 mg BID
Patients enrolled at 800 mg twice daily under fasted conditions
Safety Expansion Set 800 mg QD
Safety expansion group patients enrolled at 800 mg once daily under not fasted conditions.
| Group | Source count |
|---|---|
| 25 mg QD | 1 |
| 50 mg QD | 1 |
| 100 mg QD | 1 |
| 200 mg QD | 2 |
| 400 mg QD | 10 |
| 800 mg QD Fasted | 18 |
| 800 mg QD Not Fasted | 13 |
| 1000 mg QD | 7 |
| 1200 mg QD | 6 |
| 400 mg BID | 4 |
| 600 mg BID | 6 |
| 800 mg BID | 5 |
| Safety Expansion Set 800 mg QD | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 25 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| 400 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| 800 mg QD Fasted | 0 | Not reported | Not reported | Not reported | Not reported |
| 800 mg QD Not Fasted | 1 | Not reported | Not reported | Not reported | Not reported |
| 1000 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| 1200 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| 400 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| 600 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| 800 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Safety Expansion Set 800 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 6
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- Certain toxicities will be considered dose-limiting unless clearly attributable to an extraneous cause, such as underlying disease.
- groups
- description
- Patients who received doses at 25 mg once daily under fasted conditions.
- id
- OG000
- title
- 25 mg QD
- description
- Patients who received doses at 50 mg once daily under fasted conditions.
- id
- OG001
- title
- 50 mg QD
- description
- Patients who received doses at 100 mg once daily under fasted conditions.
- id
- OG002
- title
- 100 mg QD
- description
- Patients who received doses at 200 mg once daily under fasted conditions.
- id
- OG003
- title
- 200 mg QD
- description
- Patients dosed at 400 mg once daily under fasted conditions
- id
- OG004
- title
- 400 mg QD
- description
- Patients enrolled at 800 mg once daily under fasted conditions
- id
- OG005
- title
- 800 mg QD Fasted
- description
- Patients enrolled at 800 mg once daily under not fasted conditions
- id
- OG006
- title
- 800 mg QD Not Fasted
- description
- Patients enrolled at 1000 mg once daily under not fasted conditions
- id
- OG007
- title
- 1000 mg QD
- description
- Patients enrolled at 1200 mg once daily under fasted conditions
- id
- OG008
- title
- 1200 mg QD
- description
- Patients enrolled at 400 mg twice daily under not fasted conditions
- id
- OG009
- title
- 400 mg BID
- description
- Patients enrolled at 600 mg twice daily under not fasted conditions
- id
- OG010
- title
- 600 mg BID
- description
- Patients enrolled at 800 mg twice daily under fasted conditions
- id
- OG011
- title
- 800 mg BID
- param Type
- NUMBER
- population Description
- DLT-Evaluable
- reporting Status
- POSTED
- time Frame
- After the first dose of treatment for up to 21 days.
- title
- Number of Dose Limiting Toxicities as a Determinant of the Recommended Phase 2 Dose (RP2D)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice